FDA product code · Anesthesiology · Class 2
BZD: Ventilator, Non-Continuous (Respirator)
BZD is FDA's product code for "Ventilator, Non-Continuous (Respirator)": a Class 2 device classified under 21 CFR 868.5905, reviewed by the Anesthesiology panel.
510(k) review time for BZD
Across 58 510(k) clearances under BZD decided from 2018-01-01 to 2026-10-06, the median was 212 days from FDA receipt to decision. Half took between 141 and 266 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.
| Fastest | 22 |
|---|---|
| 25th percentile | 141 |
| Median | 212 |
| 75th percentile | 266 |
| 80th percentile | 269 |
| 90th percentile | 321 |
| Slowest | 471 |
| Year | Median days | n |
|---|---|---|
| 2018 | 280 | 5 |
| 2019 | 231 | 6 |
| 2020 | 137 | 6 |
| 2021 | 192 | 6 |
| 2023 | 204 | 5 |
| 2024 | 132 | 10 |
| 2025 | 189 | 7 |
| 2026 (to 10-06, partial) | 213 | 9 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
BZD in the public FDA record
| 510(k) clearances, all years | 461 |
|---|---|
| Device recalls | 81 |
| Establishment listings | 730 |
| GUDID device identifiers | 5,511 |
Counts of records, not of devices or events. Adverse event reports for BZD are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite BZD
14 FDA recognized consensus standards cite BZD, 2 of them recognized only in part, among them ISO 17510 First Edition 2015-08-01; ISO 80601-2-74 First edition 2017-05; ISO 80601-2-70 Second edition 2020-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-106 ISO 17510 First Edition 2015-08-01 (partial recognition) — Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
- 1-138 ISO 80601-2-74 First edition 2017-05 — Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- 1-151 ISO 80601-2-70 Second edition 2020-11 — Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
- 1-173 ISO 18562-1 Second edition 2024-03 (partial recognition) — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- 1-174 ISO 18562-2 Second edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- 1-175 ISO 18562-3 Second Edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
- 1-176 ISO 18562-4 Second Edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
- 1-177 ISO 80601-2-74 Second edition 2021-07 — Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- 1-189 ISO 4135 Fourth edition 2022-01 — Anaesthetic and respiratory equipment - Vocabulary
- 1-197 ISO 17510 Second Edition 2025-11 — Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
- 1-199 ISO 80601-2-70 Third edition 2025-11 — Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
- 1-62 ISO 5356-1 Third edition 2004-05-15 — Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- 13-74 IEEE Std 11073-10424-2014 — Health informatics - Personal health device communication Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
- 13-94 ISO IEEE 11073-10424 First edition 2016-06-15 — Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.